US9351739B2 - Tunneling device - Google Patents

Abstract

A tunneling device (10) for introduction into a body via a linearly extending guide (100) is formed as an elongated tunneling device (10) having an end portion (10E) bent to a predefined curvature. The elongated tunneling device (10) when confined in the linearly extending guide (100) is confined lengthwise in the guide (100). Upon movement of the tunneling device, advancing past the guide (100) into the body, the end portion (10E) of the tunneling device (10) returns to the predefined curvature without requiring any external physical resistance of load forces to initiate the bending.

Description

TECHNICAL FIELD

The present invention relates to a device for use in treatment of acute vertebral compression fractures for introduction into a vertebral body through a single straight passage formed through cortical bone into the cancellous bone via a straight conduit or sleeve wherein the device when entering past the cancellous conduit or sleeve into the bone cavity transitions from straight to curved.

BACKGROUND OF THE INVENTION

Treatment of vertebral compression fractures commonly employs vertebroplasty and kyphoplasty techniques. Vertebroplasty employs a percutaneous injection of PMMA (polymethylmethacrylate) in a fractured vertebral body via a trocar and cannula.

Kyphoplasty is a modification of percutaneous vertebroplasty. Kyphoplasty involves a preliminary step consisting of the percutaneous placement of an inflatable balloon tamp in the vertebral body. Inflation of the balloon creates a cavity in the bone prior to cement injection. The proponents of percutaneous kyphoplasty have suggested that high pressure balloon-tamp inflation can at least partially restore vertebral body height. In kyphoplasty, some physicians state that PMMA can be injected at higher viscosities and lower pressures into the collapsed vertebra since a cavity exists, when compared to conventional vertebroplasty.

Often in employing Kyphoplasty two straight entries are made into the spine and the inflatable tamp balloons are inflated to form two cavities into which a bone hardening stabilizing cement can be injected. These two points of entry are required because the balloon when entering straight is offset to the left or the right of a midline of the vertebrae as shown in prior artFIG. 1 illustrating one of the inflated balloons.

As a result, to expand the vertebrae to its normal or close to normal original height, the balloon tamp is inflated to lift both sides of the compressed vertebrae. Ideally, the procedure should position the inflatable balloon tamp so it is centered crossing the midline. To accomplish this, the tunneling device must be manipulated in some way to create a path that crosses the midline.

One way is to provide a steerable device; these devices are made of stainless steel and have an internal tensile member that collapses a hinged portion of the outer shaft causing the tip to deflect. This results in a wide windshield wiper motion or sweeping path that does not form a precise tunnel that a balloon tamp can follow to a desirable known position. Steerable devices typically are made as multi-piece structures which are limited in strength running the risk of breakage and leaving portions of a broken device in the patient. These steerable devices all require a physical external manipulation or load to steer the tunnel device.

An alternative is a tunnel device having slots cut in a shaft or cannula to create an effective hinge that collapses under a load or resistance as the device advances in the soft cancellous bone tissue. These slots are cut such that the device bends along a curvature compressing the slots to close along the inside of the radius of curvature, preferably completely collapsing the slot that is to abut the side wall of the adjacent cut out wall. This abutting relationship strengthens the device as it tunnels through the tissue. In this prior art solution the desired curvature can only be achieved by the slots or cuts collapsing under the load created by the patient's tissue resisting the tunnel movement, accordingly, dependent of the patient's anatomy and the force required to close the slots, the device may have an indeterminate tunnel path. In fact, the device may only turn or bend when it upon contact with the hard cortical bone on the opposite side of the vertebrae. The functionality of these devices is dependent on the patient's bone density. These type devices may deflect prematurely, effectively creating a “wind-shield wiper” type cavity in comparatively dense bone, e.g. partially healed fracture, or the device may not deflect at all due to various pathologies that decrease bone density, e.g. osteoporosis.

Ideally, the tunnel device must be capable of achieving a consistent and predictable path that, in the case of vertebrae compression fracture repair, cross the midline to create a balloon tamp path that forms a cavity in the optimal location so the procedure can be accomplished with a single, preferably, small opening.

While the tunnel device of the present invention addresses these issues, it has further applications in any procedure where a single surgical entry requires curvature or bend in a path after entry into a body. This is made possible by the invention as disclosed herein as follows.

SUMMARY OF THE INVENTION

A tunneling device for introduction into a body via a linearly extending guide is formed as an elongated tunneling device having an end portion bent to a predefined curvature. The elongated tunneling device when confined in the linearly extending guide is confined lengthwise in the guide. Upon movement of the tunneling device, advancing past the guide into the body, the end portion of the tunneling device returns to the predefined curvature without requiring any external physical resistance of load forces to initiate the bending.

Preferably the tunneling device is an elongated rod. The rod can be a solid or non-hollow structure or optionally a hollow tube. The entry end portion can have a predefined curvature having one or more predetermined radii of curvature. In one embodiment, the curvature is defined by a single constant radius. Preferably, the device is curved such that a tangent to the maximum curvature at the end or tip of the entry end portion is offset from the straight projected path of the guide, inclined at a positive angle greater than 0 degrees, preferably at least 30 degrees, more preferably 45 degrees or more relative to the guide. This insures the tunneling device is sufficiently curved at the entry end portion when entering a vertebral body to cross a midline of the vertebrae for creating a path to properly center position a single balloon tamp as a functional example. Other examples requiring a curved tunnel device path include, but are not limited to positioning the device in a damaged soft tissue disk between adjacent vertebrae to facilitate delivery of biological tissue regeneration compositions including, but not limited to stem cells, collagen and additional dish tissue, beads or allograft particles or combinations thereof.

Preferably, at least the entry end portion of the tunneling device, if not the entire tunneling device is made from a shape memory material. The shape memory material of the device can be in a rod shape having a pre-set memory pre-set by heat to the predefined curvature. The shape memory material can be a metal or a polymer or a metal alloy. The metal alloy can be nickel titanium (NiTi) preferably nitinol (Nickel Titanium Naval Ordinance Laboratory). Alternatively, the shape memory material can be a ferromagnetic material that changes shape when exposed to a magnetic field to a predefined curvature to a pre-set defined curvature.

In the preferred embodiment, the tunnel device when formed from a rod includes a plurality of cut slots spaced on the rod along the entry portion. The slots are cut on an exterior side of the rod opposite the one or more radii of curvature. The inside surface of the rod is preferably uncut or smooth on the side adjacent the radius of curvature so the opposite outside surface having the cut slots align with the curvature. The cut slots open wider upon bending to the defined curvature. The cut slots are cut deep enough to provide sufficient flexibility in the curved entry end to allow it to easily straighten when confined in the guide, but by being on the opposite side of the radius of curvature insures the device is stiff in the tunneling direction to form the curved path in the soft tissue. This also insures the device can bend to its predefined curvature without any assistance or interference to the device returning to its predefined curvature by external steering forces or requiring any tissue resistance to achieve the bend. In fact, the device simply finds the correct pre-set predefined curvature simply by advancing past the confinements of the guide without any bending assistance. The guide preferably is a cannula device and due to the construction of the tunnel device, the cannula can be of an extremely small diameter, in one embodiment only 2 or 3 mm in diameter and the rod being smaller in size, about the size of a 10 to 13 gauge wire, slips easily in said guide cannula. This insures this is one of the smallest and most minimally invasive devices available for these types of procedures and it can further accomplish its task with only one single point of entry.

DEFINITIONS

“Bone fill, fill material, or infill material or composition” includes its ordinary meaning and is defined as any material for infilling a bone that includes an in-situ hardenable material or that can be infused with a hardenable material. The fill material also can include other “fillers” such as filaments, microspheres, powders, granular elements, flakes, chips, tubules and the like, autograft or allograft materials, as well as other chemicals, synthetics, pharmacological agents or other bioactive agents.

“Flowable material” includes its ordinary meaning and is defined as a material continuum that is unable to withstand a static shear stress and responds with an irrecoverable flow (a fluid)—unlike an elastic material or elastomer that responds to shear stress with a recoverable deformation. Flowable material includes fill material or composites that include a fluid (first) component and an elastic or inelastic material (second) component that responds to stress with a flow, no matter the proportions of the first and second component, and wherein the above shear test does not apply to the second component alone.

The terms “Substantially” or “substantial” as used herein may be applied to modify any quantitative representation which could permissibly vary without resulting in a change in the basic function to which it is related.

“Osteoplasty” includes its ordinary meaning and means any procedure wherein fill material is delivered into the interior of a bone.

“Vertebroplasty” includes its ordinary meaning and means any procedure wherein fill material is delivered into the interior of a vertebra.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described by way of example and with reference to the accompanying drawings in which:

FIG. 1 is an image of a conventional straight insertion of a balloon tamp showing the offset relative to the midline of the vertebrae.

FIG. 2 is a photograph of a single entry into a vertebral model showing how the tunneling device curves to form a path crossing the midline.

FIG. 3 is a perspective view of the end portion of the tunneling device of the present invention.

FIG. 3A is a side view of the tunneling device of the present invention.

FIG. 3B is an enlarged view of the cut slots on the backside of the present invention.

FIG. 4 is an exploded view of the tunneling device of the present invention with an exemplary handle assembly.

DETAILED DESCRIPTION OF THE INVENTION

With reference toFIG. 1, a balloon tamp200 is shown extending through a guide sleeve orcannula100. The balloon tamp200 is shown in an inflated condition. The balloon tamp200 when expanded, compresses the soft tissue orcancellous bone4 such that avoid cavity5 is created. When the straight line incision oropening3 is created for theguide sleeve100, it is known that the balloon tamp200 when projecting inwardly on a straight line path is off center of the vertebrae. By being off the midline ML, thecavity5 created is biased to the left or right side of the midline ML. As a result of this alignment relative to the midline ML, it is important that two openings are provided and a secondary procedure is applied on the opposite side (not illustrated). When that occurs, twocavities5 are created to help stabilize the bone when bone cement or bone filler is added to thevertebral body2 in a kyphoplasty procedure. By requiring twoopenings3 to be created, the patient is subjected to twice the amount of trauma, and while these procedures are minimally invasive, thevertebral body2 itself is in need of repair and therefore one should try to minimize the structural intrusion into thevertebral body2 as much as possible. To accomplish this, various devices have been employed to try to provide a curved or angled path into thevertebral body2 to form acavity5 in such a way to cross the rim of cortical bone so that it intersects the midline. When this is accomplished, only one incision will be required. To accomplish this, in the prior art, hinged devices have been provided that upon insertion meet the cancellous tissue and collapse along hinges closing the device in such a fashion that it can create a curved path crossing the midline. Alternatively, steerable devices have been provided wherein some mechanical mechanism and or external forces are used to manipulate the device which is inserted straight and then bent or maneuvered over; this creates a windshield wiping effect. Both of these are inferior procedures for creating a good path tunnel for the balloon tamp200 to follow. It must be remembered that the tunneling devices are primarily designed to create a path or passageway that the balloon tamp200 can easily follow upon being inserted into thevertebral body2. If a swiping action or wide path is generated, it is uncertain where the balloon tamp200 will end up as it is not effectively being guided by the passageway that was previously created. Accordingly, there is a need for an improved tunneling device in kyphoplasty procedures.

With reference toFIG. 2, theimproved tunneling device10 of the present invention is illustrated. In this illustration, theguide sleeve100 passes through the pedicle, through thecortical bone6 creating anopening3 through which thetunneling device10 can then extend. As shown, theguide sleeve100 is positioned off at an angle on the lower right hand side ofFIG. 2 and thetunneling device10 extends up into thecancellous bone4 and as thetunneling device10 leaves theguide sleeve100, thedevice10 at theend10E initiates a predefined curvature having acurvilinear path10P as illustrated. As shown, astraight line110 projecting from theguide sleeve100 which illustrates that the balloon tamp200 as visualized by the circle would be centered on the midline, but if it followed thestraight line101 would have not intersected the midline ML or at least been offset. The center of the balloon tamp200 would have been greatly offset relative to the midline ML of thevertebral body2. However, by providing acurvilinear path10P as found in the present invention, the balloon tamp200 can be easily positioned right over the midline as shown by theline110 extending tangent to the curved path and intersecting the center midline ML where the bone tamp200 will be positioned. With reference toFIG. 2, there is athird line120 shown where the curvature of thetunneling device10 at theend portion10E was increased; the balloon tamp200 can be positioned even further inwardly towards the center of thecancellous bone4 such that the balloon tamp200 can be maneuvered along a path centered along theguide path10P depending on the radius of curvature provided in thetunneling device10 of the present invention.

What is unique about thetunneling device10 of the present invention is that it achieves its predefined curvature having acurvilinear path10P without steering or any hingeable parts that collapse upon themselves due to any external resistance or forces. For example, thetunneling device10 of the present invention is pre-set with apredefined curvature10P. Thiscurvature10P is set in the material in such a fashion that thedevice10 has a curved path in its normal state, in other words once thetunneling device10 leaves the cannula or guidesleeve100, thedevice10 at thecurved end10E will automatically return to its unrestrained curved shape. This occurs the instant thedevice10 starts to leave the cannula or guidesleeve100, as such; thedevice10 provides acurvilinear path10P as illustrated inFIG. 3. An important feature of thedevice10 is unlike hinged devices wherein collapsible slots are provided, theslots20 are provided on an opposite side relative to the radius of curvature R. Hinged devices have the slots on the same side as the radius of curvature R, this allows the hinges to close upon resistance of the soft cancellous tissue as the device is driving into the vertebrae. The present invention has theslots20 on the opposite side as shown, theseslots20 actually open and are provided to allow theend portion10E of thetunneling device10 to flex sufficiently that it can be straightened inside theguide sleeve100. As illustrated, theguide sleeve100 can be a cannula having a generally straight profile such that thetunneling device10 contained therein will similarly initially be in a straight orientation prior to insertion. As thedevice10 extends from theguide sleeve100 into thevertebral body2 andcancellous tissue4 of the cavity, thedevice10 will initiate itsnatural curvature10P that has been predefined and pre-set. As shown inFIG. 3, a perspective view of thedevice10 showing the radius of curvature R and theslots20 opposite to the radius of curvature R. As illustrated, thedevice10 is made preferably of a rod of material, the rod can be solid or hollow, and preferably as illustrated it is a solid rod of material.

With reference toFIG. 3A, the length L of thedevice10 including thecurved end portion10E extending from oneend21 to theopposite end24 is sufficient to allow thedevice10 to extend outward of the cannula or guidesleeve100 when in the fully inserted position. Theend24 of the device can be provided with a handle fixed by theflats23 for an over-molded threadedportion51 that is housed inside of the handle assembly of the device that prevent rotation in the handle such that the physician can easily push the device in. Furthermore, the handle would indicate the orientation of the curve of thedevice10 so that the physician can have an appreciation of the path that thepredefined curvature10P will take when inserted into theguide sleeve100. This is important because as thedevice10 is inserted, the physician wants the curvature to be such that theend portion10E of thedevice10 as it curves crosses the midline of thevertebra2.

With reference toFIG. 3B, an enlarged portion of theslots20 on the back side oropposite side13 to the radius of curvature R is illustrated. As shown inFIG. 3A, anexemplary device10 of the present invention has a diameter of 0.0905 inches 2.3 mm and a total straightened length of approximately 8.50 inches, 216 mm and a tangent angle at the maximum point of curvature of 0, 0 being greater than 0 degrees, preferably greater than 30 degrees, more preferably greater than 45 degrees; as shown 50 degrees relative to the straight line of thedevice10 itself or theguide sleeve100 when positioned in thevertebra2. It is important to note as illustrated, the radius of curvature R is shown as a single radius of curvature R, however, multiple radii of curvature R can be used if so desired and these multiple radii of curvature R can be pre-set into thedevice10 similar to a single radius of curvature R. At the very tip ordistal end21 of thetunneling device10, the rod material that has been rounded to facilitate insertion into thecancellous tissue material4.

As illustrated inFIG. 3B, theslots20 created in the back side oropposite side13 relative to theside11 of the radius of curvature R are spaced generally uniformly along the curvature R. These slots extend inwardly at or slightly past the midline of the rod, however, leave a sufficient amount of material along thesame surface11 as the radius of curvature R such that the rod when in the straight position inside theguide sleeve100 has sufficient strength so that it can resist forces that would tend to want to close or work in an opposite direction relative to the pre-set andpredefined curvature10P to the radius of curvature R. This flexibility in the rod enables it to easily slide inside and be easily withdrawn from the cannula. It is important to note that the plurality of slots created along the surface are primarily for flexibility and during insertion it is further noted that the slots when straightened in the guide tube tend to close upon themselves. However, as soon as the rod is free, they return to their natural pre-set andpredefined curvature10P tending to open theslots20. This is opposite the hinged devices which require the slots to close upon insertion.

As shown inFIG. 4, thetunnel device10 with the predefined curvature atend portion10E can have ahandle assembly50. Theexemplary handle assembly50 has a threadedportion51 secured in a fixed way on thedevice10 rod at the distal end opposite theend portion10E; preferably, it is insert molded over theflats23 so as to prevent rotation. Ahandle portion52 fits onto threadedportion51 and is fixed so the surgeon can know the orientation of thecurved end10E. Thethird handle piece53, possessing internal threads matching the external threads of the threadedportion51, threaded onto the threadedportion51 and is fitted into thehandle portion52 round orcircular opening60. The second and third portions fit together on assembly. Thethird portion53 can be rotated clockwise to retract the threadedportion51 further into thehandle52 and retractingshaft10 and a portion of thecurved end10E back into theguide sleeve100 to facilitate extraction from the body.

As one can easily appreciate, theslots20 are provided on that portion of the rod that would normally be under tensile stresses when bent in the direction as illustrated and the smooth portion of the rod adjacent the radius of curvature R would effectively be in compression. However, these materials are generally set at this curvature and therefore the stresses of tensile and compression are not created by the curvature R, but rather there are no compressive or tensile stresses on the device as a result of the pre-set curvature because thedevice10 has been made to take this precise shape.

In order to achieve this shape, it was found that a shapememory tunnel device10 creates an optimal solution for creation of acurved path10P to cross the midline ML that can be used in this procedure. Thepath10P created can be a constant curvature R. Preferably, the predefined curvature R is set to optimize the ability of the surgeon to insert thetunneling device10 into thecancellous material4 and to be assured that thepath10P created will follow that curvature such that the balloon tamp200 when inserted will follow thepath10P created and always be centered and crossing the midline ML of thevertebra2. The advantages of thepresent device10 are that the use of shape set materials means no additional forces such as the bone resistance or mechanisms such as separate tensile members to induce a curvature are needed. The curvature is predefined and already in thedevice10 as it is leaving theguide sleeve100, it returns to its pre-set curvature automatically in the absence of any external resistance or force. In other words, the bone cavity could be filled with air or liquid and the device would simply return to itscurved path10P without any influence or force required. Thecurved path10P can be formed as a constant profile and tangent to the working cannula or guidesleeve100 it is introduced through. The design has the advantage of being constructed from one piece of material and greatly reduces the possibility of device failure or breakage during the procedure. The shape set material can be nitinol, generally a nickel titanium material. However, other materials having shape set capability are known and similarly can be used. These materials can include other metal alloys, metals and polymers that have shape set properties. Furthermore, the shape set material may be induced by using a ferromagnetic shape set material that is responsive to magnetic fields. Or alternatively, can be a temperature set or current set curvature induced device. However, it is important to note that regardless of the type of device used, that it must have the predefined curvature already pre-set when it is positioned in theguide sleeve100. As further illustrated, it is envisioned that the present device allows the following method to be employed where one would access the vertebral body placing a cannula slightly into a vertebral body just anterior to the posterior wall and keeping the cannula in place creating the passageway with the trocar, removing the trocar and then to insert thetunneling device10distal end10E into thecannula100, this will straighten thedevice10 so that it fits into thecannula100 relatively easily with minor resistance. And before advancing thedevice10 into thevertebra2, the surgeon will align the curvature portion orpath10P in the desired orientation so that theslots20 are facing to the outside of thepath10P to be created to ensure that the curvature follows a path that will cross the midline ML of thevertebra2. The surgeon will then slowly advance thedevice10 until the desired midline ML position is achieved. He can observe this using fluoroscope, x ray if so desired. Then without rotating, he will remove thedevice10 to leave a midline crossing tunnel for kyphoplasty balloon tamp200 to follow. The balloon tamp200 will then be inserted into the cannula or guidesleeve100 and slowly introduced into the path created by thetunneling device10 so that the balloon tamp200 follows the curvature precisely crossing the midline ML of thevertebra2.

This can all be accomplished with a single entry into thevertebra2. More importantly due to the construction of thetunneling device10, the overall diameter (D) of thedevice10 can be greatly reduced from what is commonly used. While the device can be of the same size as currently used, it need not be, it can be minimized further if so desired. As a result, a smaller cannula can be used with this procedure.

In the exemplary embodiment, an 11 gauge rod of nitinol material was used. This 11 gauge rod has a diameter of 2.3 mm as a result a cannula of only 2 to 3 mm can be used for this procedure. The limiting factor on using such a small diameter cannula is the ability to provide a balloon tamp200 sufficiently small to be able to be inflated to the high pressures of 400 psi or more to create the balloon tampcavity5. However, assuming that the balloon can mounted on such a small diameter this would reduce the size from the prior art from approximately 11 to 12 mm by a factor of 5 if not 6 times smaller. This greatly reduces the size of theopening3 which will further accelerate the healing of the patient. It is believed to be the most non-invasive procedure known for kyphoplasty.

It is important to note, that thedevice10 of the present invention, while being described is a vast improvement over the current techniques of kyphoplasty, thisdevice10 can also be used in other procedures and any procedure where a tunneling device is needed to create acurved path10P. This could include further applications wherein the tunneling device is provided to go into the disc material in between vertebrae and create a tunnel. The tunnels in these cases can be used to clear a path into which medicants or tissue regenerating materials can be injected once acurvilinear path10P has been created into the disc area. In such a procedure, once thetunneling device10 is removed a cannula made of a similar curvature would be provided. Preferably the cannula will be a thin walled material of nitinol with a hollow center such that medicants can be injected through the cannula directly into the path inside the disc. These and other procedures are considered possible with the use of a singleentry guide sleeve100 through which a curved component with a pre-set curvature can be provided both for tunneling and for injecting materials into the final location where the surgeon needs to deliver either medicine or bone cement or any other fluid that can be injected into a particular location. As shown, theguide sleeve100 has been provided in a straight or generally straight configuration. It is believed that theguide sleeve100 could alternatively have a slight curvature, however it is important to note that this is considered an alternative to straight, however in any event the optimal solution of the present invention is that thetunneling device10 orcannula100 depending on the procedure will have a pre-set and predefined curvature that is different and much smaller than any bowed curvature in theguide sleeve100 and that upon leaving theentry opening3 into the bone structure thetunneling device10 or cannula will automatically go back to its pre-set curvature that is different from the path of theguide sleeve100. This change in path is important in that it creates the ability to increase the curvature of the path created by thetunneling device10 and/or the path created by the cannula or for later injection of materials.

As used herein, substantially means approximately or very close to the, in the case of a straight line, a straight line.

Variations in the present invention are possible in light of the description of it provided herein. While certain representative embodiments and details have been shown for the purpose of illustrating the subject invention, it will be apparent to those skilled in this art that various changes and modifications can be made therein without departing from the scope of the subject invention. It is, therefore, to be understood that changes can be made in the particular embodiments described, which will be within the full intended scope of the invention as defined by the following appended claims.

Claims (13)

What is claimed is:

1. A tunneling device for introduction into a body via a linearly extending guide, the device comprising: an elongated tunneling device having an end portion with a predefined curvature, the elongated tunneling device when confined in the linearly extending guide is confined lengthwise in the guide; wherein upon movement of the tunneling device advancing past the guide into the body, the end portion of the tunneling device returns to the predefined curvature without requiring any external physical resistance or external load forces to initiate the bending, wherein the tunneling device is an elongated rod, and wherein the rod includes a plurality of cut slots spaced along the rod along the entry portion wherein the slots are on an exterior side of the rod opposite the radius of curvature, wherein the inside surface of the rod adjacent the radius of curvature is smooth and the outside surface aligned with the curvature has the cut slots and upon bending the cut slots open wider.

2. The tunneling device ofclaim 1 wherein the elongated rod is non-hollow.

3. The tunneling device ofclaim 1 wherein the predefined curvature of the entry end position has one or more predetermined radius of curvature.

4. The tunneling device ofclaim 3 wherein the radius of curvature is a constant.

5. The tunneling device ofclaim 3 wherein a tangent to a maximum curvature at the end or tip is inclined at an angle of 45 degrees or more relative to the straight guide.

6. The tunneling device ofclaim 3 wherein the final position of a tip of the end portion of the tunneling device is offset from a straight projected path of the linearly extending guide.

7. The tunneling device ofclaim 1 wherein at least the entry end portion of the tunneling device is made from a shape memory material, the shape memory device having a pre-set memory to bend the entry end portion to the predefined curvature.

8. The tunneling device ofclaim 7 wherein the shape memory material has a pre-set memory pre-set by heat to the predefined curvature.

9. The tunneling device ofclaim 8 wherein the shape memory material is a metal or polymer.

10. The tunneling device ofclaim 9 wherein the shape memory material is a metal alloy.

11. The tunneling device ofclaim 10 wherein the metal alloy is NiTi (Nickel titanium).

12. The tunneling device ofclaim 11 wherein the metal alloy is nitinol.

13. The tunneling device ofclaim 7 wherein the shape memory material is a ferromagnetic shape memory alloy that changes shape under a magnetic field.

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